Drug Safety Associate I career at Kaztronix LLC in Horsham

Kaztronix LLC is in need of Drug Safety Associate I on Thu, 11 Jul 2013 07:59:12 GMT. Activities Include: Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist) Confirmation of Safety Coordinator case registry data Database searches as necessary Completion of literature searches as necessary Completion of remaining case data entry, including narrative or auto-narrative Completion of risk and quality (label...

Drug Safety Associate I

Location: Horsham Pennsylvania

Description: Kaztronix LLC is in need of Drug Safety Associate I right now, this career will be placed in Pennsylvania. Further informations about this career opportunity kindly read the description below. Activities Include:
Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist)

Confirmation of Safety Coordinator ! case registry data

Database searches as necessary

Completion of literature searches as necessary

Completion of remaining case data entry, including narrative or auto-narrative

Completion of risk and quality (label, approval, manual coding & quality review steps)

Clarification of unclear or illegible information from the LSO or Call Centre

Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician

Completion of protocol request forms as necessary

Preparation of deviation memo as necessary

Request deletions as necessary

Single case unblinding

Processes and Procedures: 5% of time

Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance.

Activities Include:
Standard Operating Procedures and Working Practices

Department guidance documents
MedDRA coding dictionary and MedDRA points to consider
Understand relevant safety implications regarding contracts with operating companies and/or marketing partners

Review and make suggestions for system and procedure enhancements

5% of time = Project Work, Audits, Inspections and other Ad-hoc Requirements: Definition: Participations in BRM projects, preparations for audits and inspections

Activities Include:
Participation in inspection and audits as required (e.g., interviews)

Participation in local or global project teams

Mentoring: 10% of time

Definition: Enhancement of the formal training program, through the provision of on going, on-the-job guidance and support.

Activities Include:
Provision of on-the-job training and support to other Safety Associates as required

Personal Development: 10% of time

Definition: Continuous development of personal skills, whether task or competency related.
Activities Include:
Technical training & e-learning

Workplace shadowing

Mentoring others

Project involvement

Soft skill development activities

Other information:
Application and knowledge of Departmental processes and guidelines, regulations and regulatory guidelines, contractual arrangements, product specific information and database/systems functionality to individual case processing and evaluation. Communicate questions clearly and concisely to the appropriate audience and accompany with possible solutions.

Education/Related experience:
Registered Nurse OR

Health/Biomedical Degree OR

Licensed Practical Nurse with Bachelors degree OR

Licensed Practical Nurse without Bachelors degree, but with knowledge of drug safety usually exhibited by minimum 5 years experience in pharmaceutical safety related role.

Pharmaceutical Industry Experience Prefer! red

Required Skills/Abilities

Intermediate Informatio! n Technology Skills

Data entry experience desired

Accountability for delivery of results

Decision making skills

Problem solving skills

Proactive approach/uses own initiative

Managing own work, ability to prioritize, plan and organize work assignments and work under strict timelines

Ability to follow guidelines, working practices etc. Experience of working with SOP/SWP's preferred

Quality orientation, attention to detail/accuracy

Flexibility/Adaptability

Positive attitude

Good team player

Ability to work independently and to collaborate

Good written and verbal communication skills

Understanding of medical terminology

Ability to summarize medical information

RELATED EXPERIENCE:
Pharmaceutical industry experience

Experience with a drug safety database

Working knowledge of coding dictionaries

Practi! cal knowledge of global regulatory AE requirements

3 years experience in skills listed above.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Kaztronix LLC.

If you interested on this career just click on the Apply button, you will be redirected to the official website

This career starts available on: Thu, 11 Jul 2013 07:59:12 GMT

Apply Drug Safety Associate I Here